China Drug Master File (DMF) for APIs, packaging Materials, and pharmaceutical excipients are regulated by China NMPA formerly CFDA. The related DMF regulations and standards clarify the drug master file structure, process, requirements, timelines, and costings in the regulations listed below.
Contact Accestra Consulting Group for English translations or questions on China’s Drug Master File (DMF) requirements.
General Laws
Drug Administration Law (2019 No. 31)
The regulatory basis for the development, manufacture, business operation, practical use, supervision, and administration of drug products, substances, excipients, and packaging materials.
Provisions for Drug Registration (2020 No. 27)
The regulatory basis for DMF approval pathways in Section 3 of Chapter 3.
DMF Standards
Announcement for Adjusting Evaluation and approval for APIs, Excipients and Packaging Materials (2017 No. 146)
Basic requirements for the binding review and approval of a drug and its related APIs, excipients, and packaging materials.
Announcement on Issues Concerning the Further Improvement of Drug-related Associated Review & Approval and Supervision (2019 No. 56)
Detailed requirements for DMF filing, incl. scope of DMF, dossier requirements, filing process and timeline under the framework of binding review and approval.
Provisions for Administration of Drug-related Associated Review & Approval for APIs, Excipients and Packaging Materials (2020 Draft for Comments)
Comprehensive administrative practices of DMF filing, incl. API independent review & approval, DMF holder responsibilities & obligations, changes to approved DMFs, and product supervision by the authorities.
